BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BVI BEAVER6600

    MDR report key: 2971375 · Received February 4, 2013

    Report

    Report Number
    1211998-2013-00003
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 31, 2013
    Manufacturer
    BECTON VISITEC INTERNATIONAL, INC.
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: 03/01/2017-03/26/2017. MFG: 03/08/2012 - 04/06/2012.

    Description of Event or Problem · 1

    FINAL REPORT. BVI BECAME AWARE ON (B)(6) 2013 THAT AN INCIDENT OCCURRED ON (B)(6) 2013. VERBATIM FROM PRODUCT INCIDENT REPORTS: INCIDENT NO. (B)(4)- THE PLASTIC PART OF THE HANDLE BROKE DURING A NOSE SURGERY. THE BLADE BROKE INSIDE THE NOSE. SEVERAL BLADES HAVE BEEN BROKEN WITH THE SAME MANNER. THE HANDLE IS A BEAVER ONE. THIS INCIDENT OCCURRED IN (B)(6). BVI'S SALE REPRESENTATIVE HAS BEEN CONTACTED SO THAT HE MAY GATHER FURTHER INFORMATION FROM THE SURGEON. BVI IS IN THE PROCESS OF INVESTIGATING HIS COMPLAINT. A FOLLOW-UP MDR WILL BE FILED WITH FURTHER INFORMATION AS SOON AS POSSIBLE, BUT NO LATER THAN (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47331 BVI BEAVER6600 BEAVER MINI-BLADE GES BECTON VISITEC INTERNATIONAL, INC. NA 3020023/3022010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention